BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX PRI TIB BRNG 14X79/83

    MDR report key: 9139125 · Received October 1, 2019

    Report

    Report Number
    0001825034-2019-04366
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    September 11, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : 140054 - MAXIM POR ANA PRI FML 75 RT ¿ 010000, 11-150830 - BMET ARCOM AP PAT W/WIRE 37MM ¿ 707360, 141314 - BIOMET FINNED PRI STEM 40MM - 437850, 103531 - TI LOW PROFILE SCREW 6.5X20MM ¿ 147953, 103536 - TI LOW PROFILE SCREW 6.5X45MM ¿ 095960, 103534 - TI LOW PROFILE SCREW 6.5X35MM ¿ 173426.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT IS UNAVAILABLE BY HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE REVISION APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO POLY WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933976 MAX PRI TIB BRNG 14X79/83 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 205000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN FEMORAL COMPONENT| UNKNOWN TIBIAL TRAY